Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With … (NCT06221371) | Clinical Trial Compass
CompletedPhase 3
Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion
China391 participantsStarted 2024-01-25
Plain-language summary
The purpose of this study is to investigate the safety and efficacy of endovascular treatment with or without preceding intravenous Tenecteplase in patients with late-window (4.5-24 hours of symptom onset) acute ischemic stroke due to middle cerebral artery (MCA) M1 or proximal M2 occlusion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age≥18 years old;
✓. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment including wake-up stroke and unwitnessed stroke; onset time refers to 'last seen well time';
✓. MCA-M1 or proximal M2 occlusions confirmed by Computer Tomography Angiography (CTA)/Magnetic Resonance Angiography (MRA) that was responsible for signs and symptoms of acute ischemic stroke;
✓. Neuroimaging: target mismatch profile on CT perfusion (CTP) or MRI + MR perfusion imaging (MRP) (analyzed by perfusion analysis software with Class II and above medical device certificates) \[ischemic core volume (defined as CBF\<30% or apparent diffusion coefficient value \< 620×10-6 mm2/s) \<70mL, mismatch ratio≥1.8, mismatch volume≥15mL\];
✓. Pre-morbid mRS score ≤2;
✓. Baseline NIHSS 6-25 (both included);
✓. Written informed consent from patients or their legally authorized representative.
Exclusion criteria
✕. Patients who decline interventional therapy or intravenous thrombolysis (IVT)；
✕. Patients allergic to tenecteplase；
✕. Rapidly improving symptoms at the discretion of the investigators；
✕. NIHSS consciousness score 1a\>2, or epileptic seizure, hemiplegia after seizures or combined with other nervous/mental illness not able to cooperate or unwilling to cooperate；
What they're measuring
1
The modified Rankin Scale (mRS) score 0 to 2 at 90 days
✕. Blood glucose \< 2.8 or \> 22.2 mmol/L (point of care glucose testing is acceptable)；
✕. Active internal bleeding or at high risk of bleeding, e.g.: Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days；
✕. Any known impairment in coagulation, e.g.: If on vitamin K antagonists, then INR \>1.7 or prothrombin time \>15 seconds; if use of any direct thrombin inhibitors or new oral anticoagulants (NOACs) during the last 48 hours unless reversal of effect can be achieved with idarucizumab; values in sensitivity laboratory tests exceed the upper limit of normal \[including activated partial thromboplastin time (APTT), international normalized ratio (INR), platelet count, thrombin time (TT), or appropriate factor Xa activity assays, etc.\]; if on heparin during the last 24 hours or with an elevated aPTT greater than the upper limit of normal；